Clinical Evaluation of the Efficacy and Safety of a Medical Vaginal Device Containing Rigenase for the Treatment of Vaginosis: A Randomized Study

Abstract

Background: Vaginitis is an inflammatory process involving the vagina, expanding often to the contiguous anatomical structures (cervix and vulva). From an etiological point of view, there are mainly two types of vaginitis: specific vaginitis (due to pathogenic microorganisms) and non-specific vaginitis (also defined vaginosis), usually caused by an alteration (disruption) of the normal vaginal microflora, usually represented by the presence of Lactobacilli due to opportunist bacteria proliferation. Whereby, the first line therapeutic approach for vaginosis (which is frequently subject to self-medication) should be focused on rebalancing the flora and not on antimicrobials, reserving the latter to persistent cases that are properly characterized by appropriate microbiological tests. A new medical device is available in different formulations for the local treatment of vaginitis and, in addition, of irritative-dystrophic states of the vaginal area.

Methods: In a randomized (kind of the device used), parallel-groups, single-centered, uncontrolled design clinical study, 75 Caucasian female outpatients suffering from vaginosis were treated with the new vaginal medical device (cream, vaginal suppository, vaginal solution, gel, and foam; n = 15 in each group) for 6 days. Before (V1) and at the end of the treatment period (V2), the presence and intensity of pain, burning, itch, dry vagina sense, dyspareunia, dysuria, vaginal discharge, and vulvovaginal erythema were checked. Signs and symptoms were quantified according to the scale: absent = 0, mild = 1, moderate = 2 and severe = 3. The overall symptoms were summarized according to the total symptoms score (TSS), defined as the sum of scores of all signs and symptoms.

Results: The analysis conducted on the TSS for the intention-to-treat (ITT) population showed a statistically significant improvement of symptoms in all treatment groups (P < 0.001), with an average reduction of the initial TSS similar in the different groups and ranging between 73% and 80% (with a V2/V1 ratio of 0.27 and 0.20, respectively). No clinically significant differences were observed between the different preparation used. At the starting visit, the most common signs and symptoms were burning, leukorrhea and vulvo-vaginal erythema, each present in 62/75 patients (82.7). All signs and symptoms were significantly regressed or disappeared at the final visit in most of the cases; the improvement score was statistically significant (P < 0.05) when analyzing the total of patients, and often it resulted in a significant difference in the individual treatment groups as well, except when only a few patients had a sign/symptom at baseline. None of patients discontinued the application of the device before the schedule period. Adverse events were detected in none of the patients studied.

Conclusions: The medical device in vaginal formulations appear to be effective and safe for the local treatment of moderate-mild inflammatory-dystrophic gynecological diseases.




J Clin Gynecol Obstet. 2017;6(1):6-11
doi: https://doi.org/10.14740/jcgo424w